Cleared Traditional

K050729 - ALCON MULTI-PURPOSE DISINFECTING SOLUTION

K050729 is the FDA 510(k) clearance for ALCON MULTI-PURPOSE DISINFECTING SOLUTION by Alcon Research, Ltd.. It is a Class 2 Ophthalmic device (product code LPN) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K050729 · Alcon Research, Ltd. · Ophthalmic device
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Sep 2005
Decision
177d
Days
Class 2
Risk

K050729 is an FDA 510(k) clearance for the ALCON MULTI-PURPOSE DISINFECTING SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Alcon Research, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on September 14, 2005 after a review of 177 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Alcon Research, Ltd. devices

Submission Details

510(k) Number K050729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2005
Decision Date September 14, 2005
Days to Decision 177 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 110d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPN Accessories, Soft Lens Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - LPN Accessories, Soft Lens Products

All 52
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K050729.
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K050250 · Ciba Vision Corporation · Aug 2005
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KARATS MULTIPURPOSE SOLUTION
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